Tramadol Hydrochloride

Product NDC
63629-4900
11-digit product format
636294900
Labeler code
63629
Product ID
63629-4900_23c1d136-5e61-4a00-abcd-9043aca0fed3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tramadol Hydrochloride
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA022370
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-07-01
Marketing end
0000-00-00
Substance
TRAMADOL HYDROCHLORIDE
Active strength
150 mg/1
Pharmacologic classes
Full Opioid Agonists [MoA],Opioid Agonist [EPC]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 11 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-4900DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-0DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-1DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-2DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-3DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-4DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-5DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-6DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-7DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-8DDiscontinued by firm2026-08-17
excluded packagepackage63629-490063629-4900-9DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 3 · 132 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-4d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-8d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-0d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-9d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-6d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-5d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-7d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-4900-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-4f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-8f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-0f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-9f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-6f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-5f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-7f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-4900-2f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-82ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-02ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-92ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-62ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-52ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-72ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-4900-22ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-8a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-0a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-9a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-5a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-7a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-4900-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-8cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-0cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-9cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-6cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-5cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-7cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-4900-2cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4900-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4900-8cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4900-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-4900-0cdf11ea48f46…ba0047e9e063…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022370-001CONZIPTRAMADOL HYDROCHLORIDE100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07
N022370-002CONZIPTRAMADOL HYDROCHLORIDE200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07
N022370-003CONZIPTRAMADOL HYDROCHLORIDE300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07
N022370-004CONZIPTRAMADOL HYDROCHLORIDE150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 168 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07caaa826d4ba7…
2026-08-18 06:07:402026-07N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022370-001CONZIP100MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2010-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022370-002CONZIP200MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022370-003CONZIP300MGCAPSULE, EXTENDED RELEASE / ORALRLD2010-05-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022370-004CONZIP150MGCAPSULE, EXTENDED RELEASE / ORALRLD2011-08-01d8e5a09893c0…

Observed Orange Book patent history#

Patent history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022370-00178581182022-04-11U-1104Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022370-00278581182022-04-11U-1104Drug product5c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022370-00378581182022-04-11U-1104Drug product5c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022370-00178581182022-04-11U-1104Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022370-00278581182022-04-11U-1104Drug product5d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022370-00378581182022-04-11U-1104Drug product5d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022370-00178581182022-04-11U-1104Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022370-00278581182022-04-11U-1104Drug product4b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022370-00378581182022-04-11U-1104Drug product4b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022370-00178581182022-04-11U-1104Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022370-00278581182022-04-11U-1104Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N022370-00378581182022-04-11U-1104Drug product74a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022370-00178581182022-04-11U-1104Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022370-00278581182022-04-11U-1104Drug productbb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022370-00378581182022-04-11U-1104Drug productbb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022370-00178581182022-04-11U-1104Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022370-00278581182022-04-11U-1104Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N022370-00378581182022-04-11U-1104Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022370-00178581182022-04-11U-1104Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022370-00278581182022-04-11U-1104Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022370-00378581182022-04-11U-1104Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N022370-00178581182022-04-11U-1104Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022370-00278581182022-04-11U-1104Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N022370-00378581182022-04-11U-1104Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022370-00178581182022-04-11U-1104Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022370-00278581182022-04-11U-1104Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N022370-00378581182022-04-11U-1104Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022370-00178581182022-04-11U-1104Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022370-00278581182022-04-11U-1104Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N022370-00378581182022-04-11U-1104Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N022370-00178581182022-04-11U-1104Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022370-00278581182022-04-11U-1104Drug product3f01610625f2…
2019-12-14 00:12 UTC2019-12N022370-00378581182022-04-11U-1104Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N022370-00178581182022-04-11U-1104Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022370-00278581182022-04-11U-1104Drug productb00525d2431f…
2019-09-15 20:21 UTC2019-09N022370-00378581182022-04-11U-1104Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N022370-00178581182022-04-11U-1104Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N022370-00278581182022-04-11U-1104Drug productea99ee380514…
2019-07-19 19:46 UTC2019-07N022370-00378581182022-04-11U-1104Drug productea99ee380514…
2023-01-26 05:58 UTC2023-01N022370-00178581182022-04-11U-1104Drug product3bdfa0b2c4d7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-4900-1EA - Each63629-490027c704d2-3074-480a-a974-4e0c38301fc412015-10-02
63629-4900-2EA - Each63629-490067ef6ac0-5781-46c5-8d63-7bf3ecd654c512015-10-02
63629-4900-3EA - Each63629-4900a0a41b9f-32c2-46df-b5b5-831968f0e13d12015-10-02
63629-4900-4EA - Each63629-4900d21becf9-41ca-427b-9d99-a635c4ea66d712015-10-02
63629-4900-5EA - Each63629-4900e3b62b38-9b1a-42eb-a1dc-ceea212656fa12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRAMADOL HYDROCHLORIDEACTIVE INGREDIENT9N7R477WCKTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
TRAMADOLACTIVE MOIETY39J1LGJ30JTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
ETHYL ACRYLATE AND METHYL METHACRYLATE COPOLYMER (2:1; 750000 MW)INACTIVE INGREDIENTP2OM2Q86BITRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
GELATININACTIVE INGREDIENT2G86QN327LTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
POVIDONE K30INACTIVE INGREDIENTU725QWY32XTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
SHELLACINACTIVE INGREDIENT46N107B71OTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
SUCROSE STEARATEINACTIVE INGREDIENT274KW0O50MTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
TALCINACTIVE INGREDIENT7SEV7J4R1UTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRAMADOL HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [BRYANT RANCH PREPACK]1002

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol Hydrochloride Extended-ReleaseTRAMADOL HYDROCHLORIDETrigen Laboratories, LLCc0bc7218-3fd0-4646-96f4-25355fc84aa92026-01-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022370
application number: NDA022370
ConZipTRAMADOL HYDROCHLORIDEVertical Pharmaceuticals, LLCa65b4d05-3a1c-4aa1-848a-d20ac9aaf62f2025-12-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022370
application number: NDA022370

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-4900-06362949000015 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63629-4900-0) 2015-09-110000-00-00NoNoCurrent